Business Imperatives

A pharmaceutical company operating in the generic medicinal product segment needed to execute a Marketing Authorization (MA) transfer in Mexico under COFEPRIS regulations.
Given the variability of regulatory requirements and the technical precision needed for dossier submissions, the client sought:

  • Expert local support to manage the MA transfer process efficiently
  • Comprehensive gap analysis and technical document validation
  • Legal and pharmacovigilance representation in Mexico

Objectives

  • Ensure full compliance with COFEPRIS requirements for MA transfer
  • Align dossier content and format with local regulatory expectations
  • Minimize approval timelines and prevent submission rejections

Problem Statement

The project faced multiple regulatory and operational challenges:

  • Regulatory variability across document types and formats
  • Need for in-depth validation of technical documents and labeling
  • Absence of in-country representation to navigate legal and PV requirements
  • Risk of delays impacting market continuity for the product

Freyr Solutions and Services

Freyr Solutions and Services

Freyr LATAM provided end-to-end regulatory support, delivering:

  • Detailed documentation gap analysis to identify and address deficiencies
  • Support in preparing the dossier fully aligned with COFEPRIS standards
  • Execution of the MA transfer to a new local representative (LR) in Mexico
  • Legal representation and pharmacovigilance unit (PVU) representation for regulatory compliance
  • Compliance with COFEPRIS requirements, reducing risk of rejection
  • Significant cost and time savings through proactive gap identification
  • Stronger regulatory alignment and increased approval likelihood
  • MA successfully transferred to a new LR in Mexico
  • Full compliance achieved on first submission
  • Reduced approval timelines and ensured uninterrupted market presence

Closing Line/Value Statement

Through expert coordination and local regulatory insight, Freyr LATAM enabled a seamless MA transfer process, securing compliance, reducing risk, and ensuring the client’s product remained available in the Mexican market.